TAP Vol 1 Issue 4

Page 1

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Important perspectives 2, 3, 6, 10, 11

Oncology drug news 27

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VOLUME 1, ISSUE 4

Financial survival in oncology 30

SEPTEMBER 2010 ASCOPost.com

Editor-in-Chief, James O. Armitage, MD

Breast Cancer

Radiation Therapy Not Necessary for Some Elderly Patients with ER-positive Breast Cancer

Bevacizumab, ODAC, and the FDA

By Caroline Helwick

E

lderly women with estrogen receptor (ER)-positive early breast cancer may be able to safely forgo radiation therapy after lumpectomy, according to data from a large Intergroup trial presented at the 2010 ASCO Annual Meeting. The only significant benefit for the addition of radiation therapy to tamoxifen was a small reduction in local recurrence—an absolute 7% decline compared to tamoxifen alone.

TamRT n = 317

0.8

n (10 yr)

Proportion

0.6

0.4

Breast tumor recurrence

6 (2%)

Ultimate mastectomy

4 (2%)

Second primary cancer

36 (12%)

Distant metastasis

21 (5%)

Death 0.2

0.0

0

“At 10 years’ follow-up, 95% of the patients in each group had no distant metastases, which is essentially a 95% cure rate,” said Kevin S. Hughes, MD, a member of the Department of Surgical Oncology at Massachusetts General Hospital, Boston. The findings add further evidence that women aged 70 and older with early-stage breast cancer can undergo lumpectomy plus tamoxifen therapy alone without compromising their survival. Dr. Hughes made it clear, however, that the results cannot be applied to younger wom21 women en, for whom radiation therapy is the Tam n = 319 standard of care. n (10 yr) Dr. Hughes presented the results P = .0001 27 (9%) on behalf of the Cancer and Leukemia Group B (CALGB), the RaNS 10 (4%) diation Therapy Oncology Group NS 33 (9%) (RTOG), and the Eastern CooperaNS 16 (5%) tive Oncology Group (ECOG).

157 (33%)

156 (33%)

NS

Death from other causes

145

148

NS

Death from breast cancer

12

8

NS

2

4

6

Years

8

10

12

Recurrence Rate Differed

14

Fig. 1: Outcomes of radiotherapy/tamoxifen or tamoxifen alone after lumpectomy in elderly patients with estrogen receptor-positive breast cancer. Differences are small. Shaded green area represents 21 women (7%) who benefited by the addition of radiation compared to tamoxifen alone. Patient numbers (n) are actual numbers at 12 years’ follow-up, whereas percentages in parentheses represent the actuarial rate at 10 years. NS = not significant; Tam = tamoxifen; TamRT = tamoxifen/radiotherapy. Courtesy of Kevin S. Hughes, MD.

CALGB 9343 included 636 women age 70 and older with stage I (tumor size ≤ 2 cm), ER-positive (or ER-indeterminate), node-negative breast cancer who had a lumpectomy with negative margins. They were randomly assigned to receive tamoxifen (n = 319) or tamoxifen plus radiacontinued on page 2

Leukemia

Gabriel Hortobagyi, MD

T

he Oncologic Drugs Advisory Committee (ODAC)a of the FDA has recommended that the Agency revoke approval of bevacizumab (Avastin) in first-line treatment of metastatic breast cancer. The FDA will decide whether or not to accept this recomendation later in the year. E2100, AVADO, and RIBBON-1 clearly showed that the addition of bevacizumab increases response rate and time to progression, although for reasons not yet clear, overall survival (OS) was not prolonged, nor was there an apparent nonsignificant trend for improved survival. This makes the situation with bevacizumab continued on page 7

Dr. Hortobagyi attended the ODAC meeting as a consultant to Genentech and made a presentation in support of preserving and expanding the indications for bevacizumab. Dr. Hortobagyi indicated that “For this meeting [ODAC, July 20, 2010], the company [Genentech] provided my travel and lodging expenses. I have otherwise no financial interest in the outcome of this meeting.” a See page 2 for perspective from ODAC members.

See page 43

The full transcript of the July 20, 2010, ODAC meeting on bevacizumab may be obtained online at http://tiny. cc/2r9x6.

Or use your smartphone to access the transcript via the 2D barcode, above.

Bosutinib May Have a Major Role in CML By Alice Goodman

MORE IN THIS ISSUE

O

n the heels of the positive studies of nilotinib (Tasigna) and dasatinib (Sprycel) as first-line therapy for chronic-phase chronic myeloid leukemia (CML), promising results for another tyrosine kinase inhibitor—bosutinib—were presented at the 2010 ASCO Annual Meeting. Two separate studies reported at the meeting showed that bosutinib was effective as Use your smartphone to view the original abstracts as presented at ASCO’s 2010 Annual Meeting. See page 43 for more information about using 2D barcodes

second- and third-line therapy in patients for whom imatinib and other therapies have failed. The first study found that half of the patients who were either imatinib-resistant or imatinib-intolerant achieved a complete cytogenetic response (CCyR) with bosutinib.1 The second study suggested that bosutinib was also effective as third-line therapy in chronic-phase CML, after failure on first-line imatinib and second-line dasatinib.2 “We see very good activity for bosutinib in both second- and third-line therapy, with high levels of response,” said lead author of the first study and senior author of the second study, Jorge E. Cortes, MD,

2010 ASCO Annual Meeting Coverage

Breast cancer ������������������������������������������ 1 Hematology �������������������������������������������� 1 Head and neck cancer ������������������������� 16 Lung cancer ����������������������������������������� 25 Melanoma: A New Paradigm ���������������������� 3 Direct from ASCO ������������������������������������ 18

continued on page 8

A Harborside Press Publication


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